Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02719613

Collaborator

AbbVie (Industry)

Enrollment

Locations

Arm

86.5

Anticipated Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Elotuzumab Drug: Dexamethasone Drug: Dexamethasone Drug: Lenalidomide Drug: Bortezomib Drug: Pomalidomide Drug: Nivolumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab

Actual Study Start Date :

Jul 15, 2016

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elotuzumab This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol.	Drug: Elotuzumab Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. Other Names: BMS-901608 HuLuc63 Empliciti Drug: Dexamethasone Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study. Drug: Dexamethasone Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. Drug: Lenalidomide Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study. Other Names: Revlimid® Drug: Bortezomib Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study. Other Names: Velcade® Drug: Pomalidomide Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study. Other Names: Pomalyst ® Drug: Nivolumab Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. Other Names: Opdivo ®

Arm

Intervention/Treatment

Experimental: Elotuzumab

This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol.

Drug: Elotuzumab

Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.

Other Names:

BMS-901608

HuLuc63

Empliciti

Drug: Dexamethasone

Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study.

Drug: Dexamethasone

Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.

Drug: Lenalidomide

Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.

Other Names:

Revlimid®

Drug: Bortezomib

Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study.

Other Names:

Velcade®

Drug: Pomalidomide

Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.

Other Names:

Pomalyst ®

Drug: Nivolumab

Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.

Other Names:

Opdivo ®

Outcome Measures

Primary Outcome Measures

The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected. [Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.]

Secondary Outcome Measures

All serious adverse events (SAEs) will be collected. [Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.]
All Grade 5 adverse events (AEs) will be collected. [Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.]
All adverse events (AEs) previously not reported will be collected. [Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.]
All adverse events (AEs) leading to discontinuation will be collected. [Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol
Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
Males and Females, ages 18 and older

Exclusion Criteria:

All participants previously discontinued from an elotuzumab study for any reason
Participants not receiving clinical benefit from previous study therapy
Participants who are not medically well enough to receive study therapy as determined by the investigator

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Clinical Research Center, Inc	Tucson	Arizona	United States	85715
2	Comprehensive Blood And Cancer Center	Bakersfield	California	United States	93309
3	Robert A. Moss, Md Facp, Inc.	Fountain Valley	California	United States	92708
4	James R. Berenson, MD, Inc.	West Hollywood	California	United States	90069
5	Rocky Mountain Cancer Centers (Williams) - USOR	Denver	Colorado	United States	80218
6	Cancer Specialists of North FL	Jacksonville	Florida	United States	32256
7	Florida Cancer Specialists - North	Saint Petersburg	Florida	United States	33705
8	Emory University	Atlanta	Georgia	United States	30322
9	Investigative Clinical Research Of Indiana, Llc	Indianapolis	Indiana	United States	46260
10	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
11	Washington University School Of Medicine	Saint Louis	Missouri	United States	63110
12	Icahn School Of Medicine At Mount Sinai	New York	New York	United States	10029
13	St. Luke's University Health Network	Bethlehem	Pennsylvania	United States	18015
14	Texas Oncology	Dallas	Texas	United States	75231
15	Local Institution	Heidelberg	Victoria	Australia	3084
16	Local Institution	Antwerpen		Belgium	2060
17	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
18	Local Institution	Toronto	Ontario	Canada	M5G 2M9
19	Local Institution	Halifax		Canada	B3H 2Y9
20	Local Institution	Athens		Greece	11528
21	Local Institution	Budapest		Hungary	1097
22	Local Institution	Ancona		Italy	60126
23	Local Institution	Firenze		Italy	50134
24	Local Institution	Genova		Italy	16132
25	Local Institution	Torino		Italy	10126
26	Local Institution	Aomori-shi	Aomori	Japan	0308553
27	Local Institution	Shibukawa-shi	Gunma	Japan	3770280
28	Local Institution	Osaka-shi	Osaka	Japan	5300012
29	Local Institution	Koto-ku	Tokyo	Japan	135-8550
30	Local Institution	Chiba		Japan	260-8677
31	Local Institution	Kasama-shi		Japan	3091793
32	Local Institution	Chorzow		Poland	41-500
33	Local Institution	Warszawa		Poland	02-106
34	Local Institution	Bucuresti		Romania	030171
35	Local Institution	Lasi		Romania	700483
36	Local Institution	Toledo		Spain	45004
37	Local Institution	Cebeci Ankara		Turkey	06620
38	Local Institution	London		United Kingdom	EC1A 7BE